Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease

Asthma Clinical Trial

Official title:

Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624490
• Other study ID #: STUDY00146119
• Status: Recruiting
• Phase: Phase 1
• Start date: November 2, 2020
• Est. completion date: October 26, 2026

Study information

• Verified date: November 2022
• Source: University of Kansas Medical Center
• Contact: Cristal Monge
• Phone: 913-945-9399
• Email: chernandez[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop and evaluate the usefulness of hyperpolarized (HP) 129Xe gas MRI for regional assessment of pulmonary function.

Description:

This is an unblinded, open-label study with ~160 subjects with diagnosed pulmonary disease and ~100 healthy controls. Subjects to be enrolled will include males and females 18-80 years old. Evaluation will be on an outpatient basis. Imaging will be done on a single day and will involve administration of up to four 1-liter doses of HP 129Xe plus one 129Xe calibration dose (~300-400mL HP 129Xe). In addition to 129Xe MRI, a series of anatomical conventional 1H MR images will be collected including a localizer scan, breath-hold spin echo image, and breath-hold steady-state free precession image to highlight the vasculature. All subjects will be evaluated at one center: The University of Kansas Medical Center, KS USA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: October 26, 2026
• Est. primary completion date: October 26, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

Healthy Volunteers:

• Subject has no diagnosed pulmonary conditions
• Ability to read and understand English or Spanish

Subjects with Lung Disease:

• Subject has a diagnosis of pulmonary dysfunction made by a physician
• No acute worsening of pulmonary function in the past 30 days
• Ability to read and understand English or Spanish

Exclusion Criteria:

• MRI is contraindicated based on responses to MRI screening questionnaire
• Subject is pregnant or lactating
• Subject does not fit into 129Xe vest coil used for MRI
• Subject cannot hold his/her breath for 15-16 seconds
• Subject deemed unlikely to be able to comply with instructions during imaging
• Oxygen saturation <88% on room air or with supplemental oxygen
• Cognitive deficits that preclude ability to provide consent
• Institutionalization

Related Conditions & MeSH terms

• Asthma
• COPD
• Cystic Fibrosis
• Hypertension, Pulmonary
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Other Lung Disease
• Pulmonary Hypertension
• Pulmonary Infection

Intervention

Drug:
• Hyperpolarized Xe129
During MRI scanning, subject will inhale hyperpolarized xenon gas for a maximum of 16 seconds per scan, with a maximum of 4 MR scans + Calibration in a given imaging session.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Mario Castro, MD, MPH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RBC/Barrier Ratio	Ratio of xenon signal dissolved in RBCs to xenon signal dissolved in Barrier Tissues	Day 1
Secondary	ADC	Apparent Diffusion Coefficient of Xenon Gas in the lungs	Day 1
Secondary	Ventilation Defect Percentage	Percentage of the Lungs with ventilation signal below a threshold level	Day 1